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Dysport Adverse Events Reported to the FDA Over Time

How are Dysport adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Dysport, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Dysport is flagged as the suspect drug causing the adverse event.

Most Common Dysport Adverse Events Reported to the FDA

What are the most common Dysport adverse events reported to the FDA?

Dysphagia
126 (3.88%)
Muscular Weakness
112 (3.45%)
Dyspnoea
78 (2.4%)
Headache
73 (2.25%)
Eyelid Ptosis
70 (2.15%)
Fatigue
66 (2.03%)
Asthenia
63 (1.94%)
Dizziness
54 (1.66%)
Off Label Use
50 (1.54%)
Diplopia
49 (1.51%)
Drug Ineffective
45 (1.38%)
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Wrong Technique In Drug Usage Proce...
42 (1.29%)
Anxiety
38 (1.17%)
Dry Mouth
37 (1.14%)
Hypersensitivity
37 (1.14%)
Neck Pain
36 (1.11%)
Speech Disorder
36 (1.11%)
Product Quality Issue
35 (1.08%)
Vision Blurred
35 (1.08%)
Feeling Abnormal
30 (.92%)
Hypoaesthesia
30 (.92%)
Nausea
29 (.89%)
Swelling Face
27 (.83%)
Dysphonia
26 (.8%)
Paraesthesia
26 (.8%)
Pyrexia
24 (.74%)
Botulism
22 (.68%)
Dysarthria
22 (.68%)
Muscle Spasms
22 (.68%)
Eye Swelling
21 (.65%)
Condition Aggravated
20 (.62%)
Insomnia
19 (.58%)
Malaise
19 (.58%)
Overdose
19 (.58%)
Chest Discomfort
18 (.55%)
Chest Pain
18 (.55%)
Pain In Extremity
17 (.52%)
Throat Tightness
17 (.52%)
Visual Impairment
17 (.52%)
Influenza Like Illness
16 (.49%)
Weight Decreased
16 (.49%)
Facial Paresis
15 (.46%)
Injection Site Pain
15 (.46%)
Muscle Twitching
14 (.43%)
Rash
14 (.43%)
Tremor
14 (.43%)
Activities Of Daily Living Impaired
13 (.4%)
Fall
13 (.4%)
Respiratory Disorder
13 (.4%)
Vertigo
13 (.4%)
Hypoaesthesia Facial
12 (.37%)
Injection Site Swelling
12 (.37%)
Muscle Tightness
12 (.37%)
Pain
12 (.37%)
Product Reconstitution Issue
12 (.37%)
Swollen Tongue
12 (.37%)
Unevaluable Event
12 (.37%)
Depression
11 (.34%)
Eyelid Oedema
11 (.34%)
Hypotonia
11 (.34%)
Migraine
11 (.34%)
Palpitations
11 (.34%)
Urticaria
11 (.34%)
Aspiration
10 (.31%)
Back Pain
10 (.31%)
Convulsion
10 (.31%)
Disturbance In Attention
10 (.31%)
Gait Disturbance
10 (.31%)
Inappropriate Schedule Of Drug Admi...
10 (.31%)
Incorrect Dose Administered
10 (.31%)
Lower Respiratory Tract Infection
10 (.31%)
Musculoskeletal Pain
10 (.31%)
Myalgia
10 (.31%)
Refusal Of Treatment By Patient
10 (.31%)
Arthralgia
9 (.28%)
Balance Disorder
9 (.28%)
Burning Sensation
9 (.28%)
Disease Progression
9 (.28%)
Drug Hypersensitivity
9 (.28%)
Impaired Work Ability
9 (.28%)
Local Swelling
9 (.28%)
Neuromuscular Toxicity
9 (.28%)
Vomiting
9 (.28%)
Dehydration
8 (.25%)
Diarrhoea
8 (.25%)
Impaired Driving Ability
8 (.25%)
Keratitis
8 (.25%)
Lethargy
8 (.25%)
Mastication Disorder
8 (.25%)
Respiratory Failure
8 (.25%)
Road Traffic Accident
8 (.25%)
Somnolence
8 (.25%)
Transient Ischaemic Attack
8 (.25%)
Viith Nerve Paralysis
8 (.25%)
Abdominal Pain Upper
7 (.22%)
Asthenopia
7 (.22%)
Blister
7 (.22%)
Choking
7 (.22%)
Corneal Degeneration
7 (.22%)
Corneal Perforation
7 (.22%)
Disorientation
7 (.22%)

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This graph shows the top adverse events submitted to the FDA for Dysport, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Dysport is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Dysport

What are the most common Dysport adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Dysport, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Dysport is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Dysport According to Those Reporting Adverse Events

Why are people taking Dysport, according to those reporting adverse events to the FDA?

Skin Wrinkling
228
Muscle Spasticity
130
Off Label Use
110
Skin Cosmetic Procedure
62
Torticollis
28
Product Used For Unknown Indication
27
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Drug Use For Unknown Indication
18
Blepharospasm
15
Neurogenic Bladder
11
Dystonia
10
Salivary Hypersecretion
10
Eyelid Ptosis
8
Hyperhidrosis
7
Migraine
6
Facial Spasm
6
Head Titubation
5
Hypertonic Bladder
5
Therapeutic Procedure
5
Foot Deformity
5
Myofascial Pain Syndrome
5
Headache
5
Ulcerative Keratitis
4
Hemiparesis
4
Muscle Spasms
4
Drooling
4
Disability
3
Paresis
3
Tendonitis
3
Diplopia
3
Muscle Contracture
3
Muscle Relaxant Therapy
2
Conjunctivitis
2
Dysphonia
2
Myalgia
2
Cerebral Palsy
2
Meiges Syndrome
2
Ischaemic Stroke
2
Pemphigoid
2
Neck Pain
2
Hereditary Spastic Paraplegia
2
Parkinsons Disease
1
Familial Tremor
1
Micturition Urgency
1
Back Pain
1
Injection
1
Muscle Contractions Involuntary
1
Paraparesis
1
Keratitis
1
Temporomandibular Joint Syndrome
1
Muscle Rigidity
1
Essential Tremor
1

Drug Labels

LabelLabelerEffective
DysportIpsen Biopharmaceuticals, Inc.01-MAR-12
DysportMedicis Pharmaceutical Corp15-AUG-12

Dysport Case Reports

What Dysport safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Dysport. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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